MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV SCIG 26G 6MM HIGH FLO; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Patient's mother to schedule refill order of hizentra and supplies.She informed patient experiences pain with needle sets that we provide.She said there is "a plastic in the middle of it that digs into his skin" leaving it irritated.She advised his previous dispensing pharmacy sent needle sets that did not cause so much irritation.I transferred her to a pharmacist to assist with providing an alternate product.Unknown if pt missed a dose; unknown if available for return; unknown lot number.No further information known.Indication: antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia.Reported to (b)(6) by: patient/caregiver.

• Brand Name: IV SCIG 26G 6MM HIGH FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 12481148
• MDR Text Key: 272122653
• Report Number: MW5103991
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/13/2022
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1